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NHS
                                  NHS Improvement

CANCER




DIAGNOSTICS
              Heart Improvement

              A Guide to Implementing
HEART         Primary Angioplasty

STROKE
Contents
Foreword                                                 3

Purpose of this document                                 4

Introduction                                             4

Background                                               5

Current provision of Primary PCI (PPCI) in the UK        6

Challenges in developing a PPCI service                  6

Does every PCI centre need to provide 24/7 PPCI?         7

Does the size of a PCI centre affect patient outcomes?   8

Should a non 24/7 PCI centre perform any PPCI?           8

Commissioning a PPCI service                             10

Help with implementation                                 14

Summary                                                  14

Appendix 1 - Key studies in PPCI                         15

Appendix 2 - PCI consensus meeting                       16

Appendix 3 - Treatment options for STEMI                 17

References                                               18




www.improvement.nhs.uk/heart/reperfusion
A Guide to Implementing Primary Angioplasty                3




Foreword
                            In only six months since the publication of new national good practice
                            guidance on treatment of heart attack, NHS Improvement have looked
                            at the major issues and obstacles to rolling out primary percutaneous
                            coronary angioplasty (PCI) services across England and brought together
                            all their learning in this helpful commissioning guide.


                            The guide provides a brief overview of current provision of primary PCI,
                            a discussion of the issues and some useful suggestions to assist in the
planning and commissioning of primary PCI services.


I would like to thank Jim McLenachan, Sheelagh Machin and Carol Marley at NHS Improvement for
their work to support implementation of primary PCI services including their work on this document
and to thank all those in cardiac networks who have informed the production of this guide.




Professor Roger Boyle CBE
National Director for Heart Disease and Stroke
Department of Health




                                                                      www.improvement.nhs.uk/heart
4       A Guide to Implementing Primary Angioplasty




        Purpose of this document                               Introduction

        In October 2008, the Government suggested a            Evidence suggests that patients who have
        rapid expansion of coronary angioplasty (Primary       suffered a heart attack have a greater chance of
                                                               survival and recovery if they are treated in a
        Percutaneous Coronary Intervention or PPCI) for
                                                               specialist centre that provides primary
        treatment of heart attack patients in England
                                                               percutaneous coronary intervention (PPCI).
        (1). NHS Improvement (formerly the Heart
        Improvement Programme) was tasked with                 ‘SHA visions have sent a powerful message that
        facilitating the national roll-out of PPCI for heart   the most effective treatments should be
                                                               available for all NHS patients. Their plans for
        attack patients. Initial discussions with a number
                                                               transforming treatment for heart attacks vividly
        of cardiac networks revealed several obstacles
                                                               illustrate this’ (2).
        that were common to all. The aim of this
        document is to provide commissioners, strategic        The final report of the National Infarct
        health authorities (SHAs), cardiac networks,           Angioplasty Project (NIAP) was published on
                                                               20th October 2008 (1). NIAP was an
        primary care trusts (PCTs), hospital trusts and
                                                               observational study to test the feasibility of
        ambulance trusts with a synopsis of the major
                                                               establishing coronary angioplasty (Percutaneous
        issues involved in developing an equitable, high       Coronary Intervention or PCI) as the initial
        quality coordinated service for heart attack           treatment (in place of thrombolysis) for heart
        patients in line with the Lord Darzis’                 attack patients across England. The key findings
        recommendations and the requirements of                of the NIAP study were as follows:
        world class commissioning.
                                                               1. PPCI can be delivered within acceptable
                                                                  treatment times in a variety of settings.
        Its main purpose is to enable the effective
                                                               2. Direct admission to a cardiac catheter
        commissioning of evidence based care by
                                                                  laboratory is the preferred route of admission
        providing a national assessment of need,
                                                                  to achieve timely treatment. This shifts the
        reviewing current service provision and the
                                                                  onus of diagnosis onto the ambulance service
        available evidence to aid local prioritisation and
                                                                  and away from Accident and Emergency
        the specification of services to be provided.
                                                                  departments.



          As a result of their findings, the overall conclusions of NIAP were:
          1. national roll-out of PPCI is feasible over the next three years
          2. the aim should be to achieve treatment times of 120 minutes or less
          3. hybrid services offering daytime PPCI and out-of-hours thrombolysis are not
             satisfactory
          4. a PPCI service needs to be 24/7 and the procedures should be carried out in a
             centre with a sufficiently high volume of cases to maintain and develop skills.



www.improvement.nhs.uk/heart
A Guide to Implementing Primary Angioplasty           5




Background

In 2007, 77,373 PCI procedures were performed
in 98 PCI centres in the UK (3). PCI patients fall
into three main groups:

1. Patients with stable angina
These patients are referred by their general
practitioner to either a rapid access chest pain
clinic or a general cardiology clinic. They
generally undergo treadmill testing or some
other non-invasive assessment of ischaemia
followed by diagnostic coronary angiography as
a day patient procedure. If they have ongoing
symptoms, and suitable anatomy, they will be
referred for PCI. Current waiting times are
around 4-6 weeks; these are considered clinically
acceptable and are compatible with the 18 week
referral to treatment pathway provided the
waiting times for clinic appointment, non-
invasive testing and angiography, are reasonably      transferred to the PCI centre for an angiogram
short.                                                with follow-on PCI if required. Current clinical
                                                      guidelines suggest that PCI should be performed
2. Patients with non-ST elevation acute               within 72 hours of admission. NSTEACS patients
coronary syndrome (NSTEACS)                           occasionally require immediate access to a
These patients are admitted acutely through an        cardiac catheter lab because of haemodynamic
Accident and Emergency department into a              instability, ongoing ischaemia or other co
cardiology (or sometimes general medical) ward.       morbidities, but most can be treated during
They are treated initially with anti-platelet,        daylight hours.
anticoagulant and anti-anginal drugs. If they
have raised cardiac markers (e.g. troponin), or       3. Patients with ST segment elevation
ongoing symptoms, indicating that they are at         myocardial infarction (STEMI)
high risk of further events, they will usually        Immediate PCI is now the preferred treatment
undergo angiography and be considered for             (over thrombolysis) for patients presenting with
revascularisation, in the form of either PCI or       ST segment elevation MI (STEMI) provided it can
coronary artery bypass graft (CABG). If they have     be delivered within an appropriate timeframe.
been admitted to a hospital with on-site PCI, the     These patients are taken directly to the PCI
angiogram and PCI will be carried out as a single     centre for primary PCI. This should be performed
procedure. If admitted to a hospital without          as soon as possible and preferably within 120
onsite PCI, the angiogram may be carried out at       minutes of the patient first summoning medical
the admitting hospital with onward referral to        help. Primary PCI, therefore, mandates 24 hour
the PCI centre. Alternatively, patients may be        access to the cardiac catheter lab.




                                                                      www.improvement.nhs.uk/heart
6       A Guide to Implementing Primary Angioplasty




        Current provision of Primary PCI
        (PPCI) in the UK

        The current provision of PPCI in the UK shows
        huge geographical variation. In 2007-8, 27%
        of STEMI patients in England and Wales were
        treated with PPCI but the PPCI rates ranged
        from almost 100% in London and The Black
        Country to less than 10% in 13 of the 28
        cardiac networks in England (4). In some areas,     Currently, the NIAP guidance is to aim for a time
        PPCI may be offered only on a 9-5 Monday to         to treatment with PCI within 120 minutes of the
        Friday basis with patients receiving thrombolysis   patient calling for help.
        at all other times. According to the BCIS Audit
                                                            The challenge in developing a PPCI service,
        of 2007, only 22 of the 98 British PCI centres
                                                            therefore, is to ensure that most patients, at
        offered a 24/7 service for PPCI (3).
                                                            whatever time they present and wherever they
                                                            present, undergo PPCI within 120 minutes of
        Challenges in developing a PPCI service
                                                            first medical contact. This involves collaboration
        Patients have heart attacks at all times of the     between the ambulance service, the cardiac
        day and night. To be effective, all treatment,      departments, the cardiac catheter labs and the
        whether thrombolysis or PPCI, should be             Accident and Emergency departments. It is likely
        provided as quickly as possible. The key studies    that there will be individual patients where the
        of PPCI are summarised in appendix 1. PPCI has      120 minutes timeline will be difficult to meet;
        been shown to be significantly better than          for most regions of the country, however, such
        thrombolysis in preventing death, recurrent         patients represent a small minority and should
        myocardial infarction and stroke when both          not obstruct clear improvements in systems of
        treatments are administered at the same time.       care. Where the time delay for an individual
        The issue, therefore, is at what timepoint does     patient is likely to be significantly greater than
        delayed PPCI become less effective than             120 or 150 minutes, then pre-hospital
        thrombolysis? Published data (see appendix 1)       thrombolysis should be considered but the
        suggests that the mortality benefit of PPCI over    patient should then be transferred to the PPCI
        thrombolysis is lost when the delay to PPCI         centre for further evaluation and treatment as
        reaches 114 minutes. However, other data            necessary. In general, the implementation of a
        suggest that a longer time delay may be             simple protocol is likely to lead to better
        acceptable, and moreover, that the other            outcomes than any attempt to provide a more
        benefits of PPCI, such as reduction of stroke and   complex algorithm where the potential for
        reinfarction, are not lost at this time period.     confusion, or even error, is greater.




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A Guide to Implementing Primary Angioplasty                  7




When setting up a service, it is important to          normal day, and are then called back in for a
note that 120 minutes is an aspirational time to       single PPCI procedure, then the European
treatment and is not a defined quality standard.       Working Time Directive (EWTD) states that they
Based on the largest body of evidence to date,         should have 11 hours continuous rest within any
PPCI may be the optimum strategy provided the          24 hour period. If the procedure ran from 4am
call-to-balloon time does not exceed 150               until 5am, then the staff would not be expected
minutes (i.e. the equivalent of a call-to-needle       to work again until 4pm that day.
time of 30 minutes plus the 114 minutes during
                                                       The unpredictability of PPCI presentations, and
which PPCI is superior to thrombolysis).
                                                       the subsequent unpredictability of staff
At a national consensus meeting (September             availability the following day, is a problem for all
2008), chaired by Professor Roger Boyle, there         24/7 PPCI centres but may be easier to manage
was clear national consensus that cardiac              in a large centre with six catheter labs and a
networks should take the lead on developing            large staff pool than in a centre with a single
their local 24/7 PPCI service (appendix 2).            cardiac catheter lab. Some organisations (e.g.
                                                       West Midlands) have mandated that PCI centres
Does every PCI centre need to provide                  with a single catheter lab should not be set up
24/7 PPCI?                                             as PPCI centres.

There are 69 NHS PCI centres in England; less          It is important that any centre starting a primary
than one-third of these currently provide a 24/7       PCI programme understands that primary PCI is
PPCI service (4). The remaining centres provide        different from other forms of PCI. Patients are
either no PPCI service or service during restricted    sicker, complications are more frequent and
hours only (usually Monday to Friday 9-5).             there is greater requirement for intra-aortic
Working on a rate of presentation of STEMI             balloon pumping, mechanical variation etc. The
patients of 600 per million of the population per      BCIS national PCI audit shows that the mortality
annum, and on the assumption that 22% of               for primary PCI is around 4.6-4.8% (3). This is
patients present between midnight and 8am (5),         approximately six times the mortality for NSTEMI
eighteen patients, on average, will present with       PCI and more than twenty times the mortality
STEMI each night (midnight to 8am) in England.         risk for elective PCI. It therefore seems sensible
To have all 69 cath labs in England staffed and        that centres should only undertake primary PCI
available to perform PPCI, but waiting for just        if they have 24-hour consultant cardiology
18 patients, would be hugely wasteful.                 availability (i.e. a consultant cardiology rota) to
Furthermore, PCI centres with a single cardiac         manage patients following PPCI for STEMI. This
catheter lab may find their daytime work               may be an issue with some non 24/7 PCI
schedule disrupted if they attempt to run a 24/7       centres.
PPCI service. If cardiac catheter lab staff work a




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8       A Guide to Implementing Primary Angioplasty




        Local factors and local geography will influence    Should a non 24/7 PCI centre
        how many PPCI centres are required. In most         perform any PPCI?
        densely populated areas of England, particularly
                                                            If we consider a cardiac network with one 24/7
        if there are good transport links, one 24/7 PPCI
                                                            PCI centre and three PCI centres where the
        centre should comfortably be able to serve a
                                                            cardiac catheter labs are non 24/7, then there
        population of 1.5 - 2 million.
                                                            are three possible treatment scenarios for STEMI
                                                            patients: (appendix 3).
        Does the size of a PCI centre affect
        patient outcomes?                                   1.all STEMI patients are transferred directly to
                                                              the 24/7 centre. This would include any STEMI
        This has been a contentious area for a number
                                                              patients who present directly to hospitals
        of years. However, there is growing evidence
                                                              operating a non 24/7 PCI service.
        that, in the setting of acute PCI for STEMI,
                                                            2.all STEMI patients are taken to the nearest
        patient outcomes are better in centres with a
                                                              cardiac catheter lab. This means that a
        larger volume of cases. In Germany, an analysis
                                                              proportion of patients would be taken for PPCI
        of almost 28,000 patients compared outcomes
                                                              to the non 24/7 centres although the majority
        in larger with smaller centres. There were no
                                                              (those presenting between 5pm and 8am
        mortality differences for patients without a
                                                              Monday to Friday plus all weekend and Bank
        myocardial infarction. Among those patients
                                                              Holiday presenters) would be taken to the
        with an acute myocardial infarction, there was a
                                                              24/7 centre.
        stepwise (and significant) reduction in mortality
                                                            3.all STEMI patients diagnosed by the
        when moving from low volume to high volume
                                                              ambulance service are taken directly to the
        centres. Centres in the top quartile for volume
                                                              24/7 centre but the small number who self-
        (performing > 521 procedures per year) had a
                                                              present at the non 24/7 PCI centre would have
        mortality of 2.78% compared with 3.97% for
                                                              their procedure locally provided the cardiac
        centres performing 196-323 procedures per year
                                                              catheter lab was available.
        and 4.41% for centres performing less than
        166 procedures per year (6).                        All three options have their advantages and
                                                            disadvantages.
        Analysis of the greater Paris PCI registry showed
        similar results. Death rates for planned            Option 1 is the simplest from the organisational
        procedures were low and equivalent for small        viewpoint; it provides a single route of referral
        (<400 cases per year) and larger (>400 cases per    (and single phone call) regardless of the time of
        year) centres. For emergency procedures,            day or day of the week. Furthermore, with the
        however, the mortality rate was significantly       advent of designated centres for major trauma
        lower in the centres performing more than 400       and stroke disease, ambulance services are now
        cases per year (6.75% vs 8.54%, p<0.05)(7).         increasingly familiar with the concept of
                                                            bypassing a local hospital in order to deliver a


www.improvement.nhs.uk/heart
A Guide to Implementing Primary Angioplasty                  9




                                                      the ambulance is essential to allow the catheter
                                                      lab to prepare for the patient’s arrival. For out-
                                                      of-hours referrals, the pre-alert allows the staff
                                                      to travel to the hospital while the patient is
                                                      being transported. Thus a travel time of 60-90
                                                      minutes may be perfectly reasonable if this is the
                                                      time taken for all the catheter lab staff to travel
                                                      to the PCI centre and prepare for the patient’s
                                                      procedure. Provided the patient is taken directly
                                                      to the cardiac catheter lab (and not to Accident
patient to a specialist treatment centre. For this    and Emergency or to Coronary Care), then it
reason, this is the preferred option in many areas    should still be possible to meet the 120 minute
of the country (London, Newcastle, South Tees,        call-to-balloon time. Door-to-balloon times may
West Yorkshire, and Greater Manchester).              be affected by the size of the centre. During
                                                      normal working hours, door-to-balloon times
Option 2 is organisationally more complex but
                                                      may be shorter in a 24/7 centre with six cardiac
provides shorter transport times for weekday
                                                      catheter labs, four of which are engaged in PCI
daytime presenters. Some ambulance services
                                                      than in a non 24/7 centre with a single cardiac
prefer this option because their vehicles are less
                                                      catheter lab, particularly if the pre-alert time is
likely to be ‘off site’ during the day. However,
                                                      short. However, the balance between a shorter
many ambulance service Medical Directors say
                                                      transport time and a possibly longer door-to-
the uncertainty about what to do with a patient
                                                      balloon time will depend on local geography
at 8.30 am or 4.45 pm makes this system
                                                      and will need to be monitored closely, whatever
unwieldy. If this option is considered further, the
                                                      option is chosen.
non 24/7 centre must make an absolute
commitment to provide PPCI between the                Regardless of where the PPCI procedures take
agreed hours every normal working day                 place, consideration should be given to those
regardless of other commitments.                      interventionists working at non 24/7 centres
                                                      contributing to the regional out-of-hours on-call
Option 3 is a variation of option 2; it has the
                                                      rota. There are 547 trained interventional
disadvantage that the 9-5 centre will see very
                                                      cardiologists in the UK (3). If out-of-hours PPCI is
few PPCI patients and will struggle to maintain
                                                      provided by 20-25 centres in the UK, then the
and develop skills.
                                                      on-call frequency could be as low as one night
When planning services, it is important to realise    every three weeks. In practice, those at the non
that the travel time (in the ambulance) is only       24/7 centres will have other on-call
one component of the call-to-balloon time. The        commitments and a full commitment to the rota
door-to-balloon time within the hospital is also      is often not practical. Nevertheless, any
an important component. A ‘pre-alert’ call from       contribution to the regional rota at the 24/7


                                                                        www.improvement.nhs.uk/heart
10      A Guide to Implementing Primary Angioplasty




        centre is generally welcomed. An appropriate
                                                              In West Yorkshire, PPCI commenced in
        programmed activity (PA) calculation for the
                                                              Leeds in April 2005 and was later rolled
        average amount of work done during on-call
                                                              out to the rest of the network. For each
        should be made and this reimbursed from the           patient, Leeds PCT paid the acute PCI
        24/7 to the non 24/7 trust. This system already       tariff. However, it no longer paid the MI
        works well in some areas of the country and           tariff and had to pay for a smaller number
        helps to maintain and develop the skills of those     of subsequent angiography and PCI
        interventionists based at hospitals not providing     procedures. This resulted in a saving to
        a PPCI service.                                       Leeds PCT of £750,000 in the first year.
                                                              For subsequent years, Leeds PCT reduced
        Commissioning a PPCI service                          the SLA with Leeds Teaching Hospitals
                                                              NHS Trust for MI stays and subsequent
        In some ways, commissioning of a PPCI service         angiograms and the ‘savings’ were
        differs from the commissioning of other new           directed into other services (8).
        clinical services. The procedure (PCI) is already
        commissioned. Initial fears that commissioning a    Indeed, the overall cost to commissioners of
        PPCI service might lead to a substantial growth     treating STEMI may fall following the
        in total PCI numbers have been unfounded. In        introduction of PPCI.
        West Yorkshire, the introduction and roll-out of
        PPCI to a population of around three million has    Steps:
        led to no increase in absolute PCI numbers, even
        though PPCI now makes up 30% of the total           1. A network-wide discussion on the
        PCI procedures. The reason for this is clear:       number and location of centres that will
        when thrombolysis was the standard treatment        provide PPCI. This will be determined by
        for STEMI patients, around 60-70% of                geography, access to the centres and the
        thrombolysed patients underwent angiography         expected number of PPCI cases. These data
        and/or PCI within six months of their initial       should be available from the MINAP report (4).
        presentation. Therefore, a policy of PPCI brings    As noted earlier, this is unlikely to represent a
        forward the PCI procedure to the time when the      significant increase in PCI activity unless the pre-
        patient has most to gain.                           existing level of intervention in the network was
                                                            particularly low. The service may be provided by
                                                            a mixture of 24/7 and non 24/7 PCI centres (see
          The NIAP recommendation was simply that:          above). If a PCI service serves a population of
      “the procedures should be carried                     500,000, and runs a 24/7 service, then it would
                                                            expect to see around 300 PPCI patients per
       out in a centre with a sufficiently
                                                            annum. If the service is 9-5, 365 days per year,
       high volume of cases to maintain                     then it would expect to treat around 58% of all
                     and develop skills.”                   PPCI patients in the area. If the service runs 9-5,


www.improvement.nhs.uk/heart
A Guide to Implementing Primary Angioplasty              11




Monday to Friday, and is closed on Bank                 2. Equality Impact Assessment. Local data
Holidays, then it would expect to perform PPCI          and community intelligence will be required to
on approximately 40% of all STEMI patients              assess the needs of the population and to
from its catchment area (i.e. 2-2.5 procedures          provide equitable access for patients in rural
per week on average).                                   areas will require longer ambulance journey
                                                        times. In areas with very long travel times to the
There is a risk of very patchy and fragmented
                                                        PPCI centre it may be appropriate to continue
services being developed. Smaller PCI centres
                                                        with a pre hospital thrombolysis service with the
(e.g. with two or three PCI operators) may feel
                                                        patients then transferring to a PCI centre for
threatened by the loss of some PCI activity to
                                                        angiography/PCI within a 24-hour timeframe (9).
their local 24/7 PCI centre and may feel obliged
to develop a 9-5 Monday to Friday PPCI service.         3. Setting up a 24/7 service. The 24/7 PCI
It is clearly important that the best interests of      centre is likely to require additional non-medical
the patients are the primary concern. As noted          staff (nursing staff, cardiac physiologists and
earlier, the mortality risk for STEMI patients          radiographers) to cope with the increased
undergoing PCI is approximately six times the           frequency of out-of-hours and weekend
mortality for non-STEMI PCI. These patients,            working. With a high expectation of night
therefore, require access to a highly trained team      working, there may be a knock-on effect to
in the catheter laboratory and in the coronary          daytime staffing which needs to be considered.
care unit. If the procedure has been complicated,       If the European Working Time Directive is
patients will require further specialist cardiology     observed, then staff who work after midnight
input at any time of the day or night. For this         will normally be allowed 11 hours’ rest prior to
reason, setting up a 9-5 PPCI service in a hospital     returning to work. This will require a larger
without a consultant cardiology rota is not             workforce and flexibility in the workforce. Under
recommended. When considering 9-5 centres,              Payment by Results (PBR), there is no additional
the network, the commissioners and the                  funding for a PPCI procedure carried out at 3am
ambulance trust(s) need to balance carefully the        compared to one at 3pm. As mentioned earlier,
benefits of shorter transfer times for a minority       the increase in total PCI numbers may be very
of the patients presenting for PPCI against the         modest. The PPCI centre, therefore, will incur
published data (outlined above) relating larger         additional staffing costs which will not
procedural volumes to better patient outcomes.          necessarily be balanced by extra income under
At present, there is no national recommendation         PBR. Furthermore, some staff members may
on the minimum number of PPCI procedures                have chosen cardiac catheter laboratory work
that should be performed by any centre.                 specifically because the daytime hours of
However, one advisory group has recommended             working, with a low frequency of night-time
that only PCI centres performing more than 400          working, suited their domestic circumstances.
PCI procedures per annum should be
commissioned as primary PCI centres.


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12      A Guide to Implementing Primary Angioplasty




        The shift towards more frequent out-of-hours
        working will require careful planning. If additional
        staff are not employed, the delivery of daytime
        cardiac catheter lab work (elective PCI,
        angiography, pacing, EP etc) is likely to be
        compromised.

        4. Return to local hospital. One of the
        advantages of a PPCI policy is that it shortens
        hospital stay when compared to thrombolysis,
        most patients being discharged on day three.
        Depending on local arrangements, the patient
                                                               straightforward when there is a specific tariff for
        may remain in the PCI centre and then be
                                                               rehabilitation which will usually be paid to the
        discharged directly home; in other centres,
                                                               local hospital.
        patients are transferred back to the local hospital
        a few hours after the PPCI procedure. This is
                                                               6. Commissioning of the ambulance service.
        sometimes referred to as ‘repatriation’ although
                                                               The ambulance service is the cornerstone to
        the patient may well have been admitted directly
                                                               providing timely PPCI. As with stroke and serious
        to the PCI centre via the ambulance service and
                                                               trauma, PPCI represents a major change in the
        may never have been in the local hospital.
                                                               function of ambulance personnel who now play
        5. Impact of PPCI on the DGH. A policy of              a key role in diagnosis and in determining where
        PPCI will have a major effect on the function of       the patient will be best treated. Setting up the
        the district general hospital (DGH) coronary care      service, therefore, requires careful modelling of
        unit (CCU). The emphasis on the DGH CCU will           exactly what is required. In general, the
        change from treating thrombolysed STEMI                ambulance service is not required to make
        patients to treating post-PPCI patients and            additional emergency journeys with STEMI
        NSTEACS patients. PPCI will also have an impact        patients although the journeys will be longer if
        on DGH income. In some centres, because of             the patient bypasses the local hospital. Return of
        the overall savings, PCTs have agreed to pay a         the patient to the local hospital after PPCI may
        PCI tariff to the PCI centre and an additional         be a new service; in many instances, however,
        ‘short stay tariff’ to the DGH which takes the         patients received thrombolysis at their local
        patient soon after the PPCI procedure. In other        hospital and were then transferred, by
        centres, a ‘tariff split’ arrangement has been         ambulance, to a PCI centre. In each network,
        discussed with, for example, 80% of the PCI            the amount of additional ambulance activity
        tariff going to the PCI centre and 20% to the          required will depend on the model of PPCI
        hospital which takes the patient within 24 hours       delivery chosen and on the pre-existing
        of the procedure. This may become more                 arrangements for inter-hospital transfer of MI



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A Guide to Implementing Primary Angioplasty               13




                                                       patients and their families developing
                                                       misconceptions about heart attack as an
                                                       acute self limiting event rather than a marker of
                                                       a long term condition (10). They believe the
                                                       problem has been ‘fixed’. If the long term nature
                                                       of the condition is not appreciated by the
                                                       patient and their family, then the impact of
                                                       advice about behaviour modification such as
                                                       smoking cessation, weight loss, and regular
                                                       exercise may be reduced. The provision of
patients. Isochrone mapping of journey times           information about prescribed medications,
may be a useful tool when calculating journey          dietary recommendations and levels of physical
times to PPCI centres.                                 exercise are important for patients and their
                                                       families. Additional support may be required for
7. Rehabilitation and longer term
                                                       elderly patients, those managing multiple co
management. Patients treated with primary
                                                       morbidities or those who have experienced
angioplasty have a shorter hospital stay
                                                       complications (eg cardiac arrest). Patients and
characterised by transfers across clinical settings.
                                                       families are not always certain of where hospital
An unintended consequence of this is the
                                                       care ‘finishes’ and community care ‘begins’ so
reduction in time available for health
                                                       information about who they may contact if they
professionals to provide the patient and family
                                                       experience difficulties during early recovery is
with health education and psychological
                                                       valuable.
support. To ensure that patients do not ‘fall
through gaps’ clear communication is required
between acute services and the primary care
trust. The involvement of cardiac rehabilitation
teams during the early planning phase of
services is recommended. Cardiac rehabilitation
services may require additional resources with
emphasis upon service delivery in a primary care
rather than acute care setting. Effective
discharge planning and timely referral for cardiac
rehabilitation supports early recovery and
secondary prevention.

8. Impact of families and carers. Another
unintended consequence of PPCI is that the
short hospital stay may contribute towards



                                                                         www.improvement.nhs.uk/heart
14      A Guide to Implementing Primary Angioplasty




        Help with implementation                           Summary

        NHS Improvement - Heart Improvement                The implementation of PPCI as the default
        Programme is providing support for the             treatment nationally for patients with STEMI cuts
        implementation of PPCI as stated in ‘Treatment     across many boundaries. Those cardiac networks
        of Heart Attack National Guidance’. This support   who have not yet implemented PPCI can learn a
        is in the form of a series of themed national      great deal from the areas of the country where
        meetings and bespoke support for cardiac           the service is already up and running. The
        networks and SHAs from the national clinical       experience of the North East of England, one of
        lead and national improvement lead for             the NIAP pilot sites, summarises the major
        reperfusion. Up to date information, resources     issues. They concluded that the implementation
        and case studies are available on a dedicated      of PPCI across the region revolved around
        web page on the NHS Improvement website.           finding acceptable answers to five key questions:
        Further information and contact details
                                                           1. What are the patient pathways associated
        can be found on the website at:
                                                              with the implementation of PPCI?
        www.improvement.nhs.uk/heart/reperfusion
                                                           2. What is the appropriate Payment by Results
                                                              structure for funding these pathways?
                                                           3. What are the additional ambulance services
                                                              required to support these pathways?
                                                           4. What is the knock-on impact to non-PPCI
                                                              units of moving to PPCI?
                                                           5. What are the commissioning impacts for all
                                                              PCTs and acute trusts in the region, including
                                                              the one-off consequences of commissioning
                                                              change and the sustained revenue
                                                              consequences and impact on system-wide
                                                              viability?




www.improvement.nhs.uk/heart
A Guide to Implementing Primary Angioplasty            15




Appendix 1: Key Studies in Primary PCI

1. Primary PCI versus intravenous                     additional ambulance journey and a delay in
thrombolytic therapy for acute myocardial             starting the reperfusion treatment. The median
infarction: a quantitative review of 23               time interval from randomization to the start of
randomised trials.                                    treatment was 20 minutes (range 15-30
The Lancet 2003;361:13-20                             minutes) for those patients in community
Keeley E, Boura J, Grines C.                          hospitals treated with thrombolysis and 90
                                                      minutes (range 74-108 minutes) for those
In this metanalysis of 23 randomised trials,
                                                      patients transported to a PPCI centre.
involving 7,739 patients, primary PCI was
associated with significant reduction in death
                                                      3. Hospital Delays in Reperfusion for ST-
(7% vs 9%), non-fatal re-infarction (3% vs 7%)
                                                      Elevation Myocardial Infarction: Implications
and stroke (1% vs 2%). However, the studies
                                                      When Selecting a Reperfusion Strategy.
included in this metanalysis relate to patients
                                                      Pinto DS, Kirtane AJ, Brahmajee K, et al.
presenting to PCI centres. In the UK, many
                                                      Circulation 2006;114:2019-2025.
patients present acutely to non-PCI hospitals.
                                                      In this observational study, the inherent delay in
2. A comparison of coronary angioplasty               PPCI was calculated by subtracting door-to-
with fibrinolytic therapy in acute                    needle times from door-to-balloon times in a
myocardial infarction.                                very large registry of 192,000 MI patients. After
Anderson HR, Nielsen TT, Rasmussen K, et al           correction for patient and hospital-based factors,
N Engl J Med 2003;349:733-742                         the timepoint at which the odds of death with
                                                      PCI were equal to those for thrombolysis
In the studies included in the metanalysis
                                                      occurred when the PCI delay (i.e. the difference
described above (Keeley et al), patients
                                                      between door-to-needle and door-to-balloon
presenting to a PCI-capable hospital were
                                                      times) was 114 minutes.
randomised to either PPCI or thrombolysis. In
this study (DANAMI-2), 1129 patients presenting
to non-PCI centres were randomised to either
immediate thrombolysis (at the community
hospital) or to transportation by ambulance to a
PCI centre for primary PCI. The primary end-
point (death, re-infarction or disabling stroke)
was significantly lower in the PPCI group than in
the thrombolysis group (8.5% vs 14.2%,
p<0.002) even though the PPCI group had an




                                                                       www.improvement.nhs.uk/heart
16      A Guide to Implementing Primary Angioplasty




        Appendix 2: National PCI Consensus Meeting

        A national PCI consensus meeting was held by         2. Workforce
        NHS Improvement on 24th September 2008.              Workforce issues for all catheter lab staff were
        Invited to the meeting were cardiac network          discussed. Centres should observe the European
        representatives and interventional cardiologists     Working Time Directive with regard to rest for
        from large (surgical) centres, from PCI centres      on-call staff who have been working during the
        without on-site surgical cover and from DGHs         night. For consultant staff, this means altering
        planning to set up PCI services. Speakers            job plans so that the consultant has no fixed
        included Dr Roger Boyle (National Director for       commitments after a night on-call. It was
        Heart and Stroke), Dr Huon Gray (Author of the       acknowledged that this may have adverse
        NIAP report) and Dr Mark de Belder (President of     effects on catheter lab scheduling and
        the British Cardiovascular Intervention Society).    productivity.
        The discussion centred on the current status of
                                                             Possible destabilisation and recruitment issues
        PCI delivery in the UK, requirements for new
                                                             were discussed. This could be destabilisation of
        centres to deliver more PCI, the role of cardiac
                                                             the DGH with deskilling of CCU staff if the care
        networks and issues around measuring and
                                                             of STEMI patients transfers from a DGH to a
        reporting quality.
                                                             24/7 PCI centre. On the other hand, 24/7
        The main areas of agreement                          working may cause some staff to move away
        consensus were:                                      from the 24/7 PCI centre to a non-24/7 PCI
                                                             centre.
        1. Networks
        Agreement was reached that networks are the          3. British Cardiovascular Intervention
        correct building blocks for planning PCI services.   Society (BCIS)
        Cardiac networks are patient focused and             The majority agreed that the BCIS peer review
        provide a forum to arrive at a clinical consensus    scheme was still required and BCIS had a role in
        on patient care. They are able to discuss the        the accreditation of new centres and in setting,
        whole patient pathway across boundaries able         and publishing, agreed standards.
        to take a strategic view and influence trusts.
                                                             4. Measuring and reporting quality
        There was also agreement that cross boundary
                                                             There was general agreement that quality in PCI
        working is required to deliver equitable services
                                                             is difficult to measure and that more robust
        for patients. Cross boundary working was
                                                             outcome data are required including evidence
        especially pertinent for working with ambulance
                                                             relating volume of activity to outcomes.
        services.




www.improvement.nhs.uk/heart
A Guide to Implementing Primary Angioplasty          17




Appendix 3: Treatment Options for STEMI

  Option 1
                                    Patient with STEMI



             Call 999                          GP                      Self presents in A&E



         24/7 heart
        attack centre



  Option 2
                                    Patient with STEMI



             Call 999                          GP                      Self presents in A&E




                         Local hospital                   Local hospital



                Out of hours               24/7 heart                 Out of hours
                  Weekends                attack centre               Weekends
               Bank holidays                                          Bank holidays



  Option 3
                                    Patient with STEMI



             Call 999                          GP                      Self presents in A&E



         24/7 heart            When catheter labs are unavailable
        attack centre
                                                                              Local hospital




                                                                    www.improvement.nhs.uk/heart
18      A Guide to Implementing Primary Angioplasty




        References

        1. Department of Health (2008) Treatment of Heart Attack National Guidance –
           Final Report of the National Angioplasty Project (NIAP)
        2. Darzi A (2008) High Quality Care for All
        3. British Cardiovascular Intervention Society (2007) Audit report
           www.bcis.org.uk/resources/audit
        4. Royal College of Physicians (2008) Myocardial Ischaemia National Audit Report (MINAP)
           How the NHS manages heart attacks
        5. Primary percutaneous coronary intervention for acute ST segment elevation
           myocardial infarction - first year’s experience of a tertiary referral centre in the UK.
           Dorsch MF, Blackman DJ, Greenwood J, et al
           Clinical Medicine 2008;8:259-263.
        6. Volume-outcome relation for contemporary percutaneous coronary interventions (PCI) in daily
           clinical practice: is it limited to high-risk patients? Results from the Registry of Percutaneous
           Coronary Interventions of the Arbeitsgemeinschaft Leitende Kardiologische
           Krankenhausarzte (ALKK).
           Zahn R, Gottwik M, Hochadel M, et al.
           Heart 2008;94:329-335
        7. Is the volume-outcome relation still an issue in the era of PCI with systematic stenting?
           Results of the greater Paris area PCI registry.
           Spaulding C, Morice MC, Lancelin B, et al.
           European Heart Journal 2006;27:1054-1060
        8. West Yorkshire Cardiovascular Network (2008) – personal communication
        9. ‘Management of acute myocardial infarction in patients presenting with persistent ST elevation’
           European Society of Cardiology Guidelines Van de Werf F, Bax J, Betriu, et al. European Heart
           Journal (2008) 29,2909-2945
        10.Primary angioplasty for heart attack: mismatch between expectation and reality.
           Astin F, Closs SJ, McLenachan JM, et al
           Journal of Advanced Nursing 2008;65:72-83

        Authors
        Dr J M McLenachan, National Clinical Lead, Reperfusion, NHS Improvement,
        Consultant Cardiologist, Leeds General Infirmary
        Carol Marley, National Improvement Lead, Reperfusion, NHS Improvement
        Sheelagh Machin, Director, Heart, NHS Improvement

        April 2009




www.improvement.nhs.uk/heart
NHS
                                                                                NHS Improvement


CANCER




DIAGNOSTICS




HEART




STROKE
              NHS Improvement

              With nearly ten years practical service improvement experience
              in cancer, diagnostics and heart, NHS Improvement aims to
              achieve sustainable effective pathways and systems, share
              improvement resources and learning, increase impact and
              ensure value for money to improve the efficiency and quality
              of NHS services.
              Working with clinical networks and NHS organisations across
              England, NHS Improvement helps to transform, deliver and
              build sustainable improvements across the entire pathway of
              care in cancer, diagnostics, heart and stroke services.



              NHS Improvement
              3rd Floor | St John’s House | East Street | Leicester | LE1 6NB
              Telephone: 0116 222 5184 | Fax: 0116 222 5101

              www.improvement.nhs.uk




              Delivering tomorrow’s
              improvement agenda
              for the NHS



                                                                                     ©NHS Improvement 2009 | All Rights Reserved
                                                                                     Publication Ref: IMP/heart0014

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A Guide to Implementing Primary Angioplasty

  • 1. NHS NHS Improvement CANCER DIAGNOSTICS Heart Improvement A Guide to Implementing HEART Primary Angioplasty STROKE
  • 2. Contents Foreword 3 Purpose of this document 4 Introduction 4 Background 5 Current provision of Primary PCI (PPCI) in the UK 6 Challenges in developing a PPCI service 6 Does every PCI centre need to provide 24/7 PPCI? 7 Does the size of a PCI centre affect patient outcomes? 8 Should a non 24/7 PCI centre perform any PPCI? 8 Commissioning a PPCI service 10 Help with implementation 14 Summary 14 Appendix 1 - Key studies in PPCI 15 Appendix 2 - PCI consensus meeting 16 Appendix 3 - Treatment options for STEMI 17 References 18 www.improvement.nhs.uk/heart/reperfusion
  • 3. A Guide to Implementing Primary Angioplasty 3 Foreword In only six months since the publication of new national good practice guidance on treatment of heart attack, NHS Improvement have looked at the major issues and obstacles to rolling out primary percutaneous coronary angioplasty (PCI) services across England and brought together all their learning in this helpful commissioning guide. The guide provides a brief overview of current provision of primary PCI, a discussion of the issues and some useful suggestions to assist in the planning and commissioning of primary PCI services. I would like to thank Jim McLenachan, Sheelagh Machin and Carol Marley at NHS Improvement for their work to support implementation of primary PCI services including their work on this document and to thank all those in cardiac networks who have informed the production of this guide. Professor Roger Boyle CBE National Director for Heart Disease and Stroke Department of Health www.improvement.nhs.uk/heart
  • 4. 4 A Guide to Implementing Primary Angioplasty Purpose of this document Introduction In October 2008, the Government suggested a Evidence suggests that patients who have rapid expansion of coronary angioplasty (Primary suffered a heart attack have a greater chance of survival and recovery if they are treated in a Percutaneous Coronary Intervention or PPCI) for specialist centre that provides primary treatment of heart attack patients in England percutaneous coronary intervention (PPCI). (1). NHS Improvement (formerly the Heart Improvement Programme) was tasked with ‘SHA visions have sent a powerful message that facilitating the national roll-out of PPCI for heart the most effective treatments should be available for all NHS patients. Their plans for attack patients. Initial discussions with a number transforming treatment for heart attacks vividly of cardiac networks revealed several obstacles illustrate this’ (2). that were common to all. The aim of this document is to provide commissioners, strategic The final report of the National Infarct health authorities (SHAs), cardiac networks, Angioplasty Project (NIAP) was published on 20th October 2008 (1). NIAP was an primary care trusts (PCTs), hospital trusts and observational study to test the feasibility of ambulance trusts with a synopsis of the major establishing coronary angioplasty (Percutaneous issues involved in developing an equitable, high Coronary Intervention or PCI) as the initial quality coordinated service for heart attack treatment (in place of thrombolysis) for heart patients in line with the Lord Darzis’ attack patients across England. The key findings recommendations and the requirements of of the NIAP study were as follows: world class commissioning. 1. PPCI can be delivered within acceptable treatment times in a variety of settings. Its main purpose is to enable the effective 2. Direct admission to a cardiac catheter commissioning of evidence based care by laboratory is the preferred route of admission providing a national assessment of need, to achieve timely treatment. This shifts the reviewing current service provision and the onus of diagnosis onto the ambulance service available evidence to aid local prioritisation and and away from Accident and Emergency the specification of services to be provided. departments. As a result of their findings, the overall conclusions of NIAP were: 1. national roll-out of PPCI is feasible over the next three years 2. the aim should be to achieve treatment times of 120 minutes or less 3. hybrid services offering daytime PPCI and out-of-hours thrombolysis are not satisfactory 4. a PPCI service needs to be 24/7 and the procedures should be carried out in a centre with a sufficiently high volume of cases to maintain and develop skills. www.improvement.nhs.uk/heart
  • 5. A Guide to Implementing Primary Angioplasty 5 Background In 2007, 77,373 PCI procedures were performed in 98 PCI centres in the UK (3). PCI patients fall into three main groups: 1. Patients with stable angina These patients are referred by their general practitioner to either a rapid access chest pain clinic or a general cardiology clinic. They generally undergo treadmill testing or some other non-invasive assessment of ischaemia followed by diagnostic coronary angiography as a day patient procedure. If they have ongoing symptoms, and suitable anatomy, they will be referred for PCI. Current waiting times are around 4-6 weeks; these are considered clinically acceptable and are compatible with the 18 week referral to treatment pathway provided the waiting times for clinic appointment, non- invasive testing and angiography, are reasonably transferred to the PCI centre for an angiogram short. with follow-on PCI if required. Current clinical guidelines suggest that PCI should be performed 2. Patients with non-ST elevation acute within 72 hours of admission. NSTEACS patients coronary syndrome (NSTEACS) occasionally require immediate access to a These patients are admitted acutely through an cardiac catheter lab because of haemodynamic Accident and Emergency department into a instability, ongoing ischaemia or other co cardiology (or sometimes general medical) ward. morbidities, but most can be treated during They are treated initially with anti-platelet, daylight hours. anticoagulant and anti-anginal drugs. If they have raised cardiac markers (e.g. troponin), or 3. Patients with ST segment elevation ongoing symptoms, indicating that they are at myocardial infarction (STEMI) high risk of further events, they will usually Immediate PCI is now the preferred treatment undergo angiography and be considered for (over thrombolysis) for patients presenting with revascularisation, in the form of either PCI or ST segment elevation MI (STEMI) provided it can coronary artery bypass graft (CABG). If they have be delivered within an appropriate timeframe. been admitted to a hospital with on-site PCI, the These patients are taken directly to the PCI angiogram and PCI will be carried out as a single centre for primary PCI. This should be performed procedure. If admitted to a hospital without as soon as possible and preferably within 120 onsite PCI, the angiogram may be carried out at minutes of the patient first summoning medical the admitting hospital with onward referral to help. Primary PCI, therefore, mandates 24 hour the PCI centre. Alternatively, patients may be access to the cardiac catheter lab. www.improvement.nhs.uk/heart
  • 6. 6 A Guide to Implementing Primary Angioplasty Current provision of Primary PCI (PPCI) in the UK The current provision of PPCI in the UK shows huge geographical variation. In 2007-8, 27% of STEMI patients in England and Wales were treated with PPCI but the PPCI rates ranged from almost 100% in London and The Black Country to less than 10% in 13 of the 28 cardiac networks in England (4). In some areas, Currently, the NIAP guidance is to aim for a time PPCI may be offered only on a 9-5 Monday to to treatment with PCI within 120 minutes of the Friday basis with patients receiving thrombolysis patient calling for help. at all other times. According to the BCIS Audit The challenge in developing a PPCI service, of 2007, only 22 of the 98 British PCI centres therefore, is to ensure that most patients, at offered a 24/7 service for PPCI (3). whatever time they present and wherever they present, undergo PPCI within 120 minutes of Challenges in developing a PPCI service first medical contact. This involves collaboration Patients have heart attacks at all times of the between the ambulance service, the cardiac day and night. To be effective, all treatment, departments, the cardiac catheter labs and the whether thrombolysis or PPCI, should be Accident and Emergency departments. It is likely provided as quickly as possible. The key studies that there will be individual patients where the of PPCI are summarised in appendix 1. PPCI has 120 minutes timeline will be difficult to meet; been shown to be significantly better than for most regions of the country, however, such thrombolysis in preventing death, recurrent patients represent a small minority and should myocardial infarction and stroke when both not obstruct clear improvements in systems of treatments are administered at the same time. care. Where the time delay for an individual The issue, therefore, is at what timepoint does patient is likely to be significantly greater than delayed PPCI become less effective than 120 or 150 minutes, then pre-hospital thrombolysis? Published data (see appendix 1) thrombolysis should be considered but the suggests that the mortality benefit of PPCI over patient should then be transferred to the PPCI thrombolysis is lost when the delay to PPCI centre for further evaluation and treatment as reaches 114 minutes. However, other data necessary. In general, the implementation of a suggest that a longer time delay may be simple protocol is likely to lead to better acceptable, and moreover, that the other outcomes than any attempt to provide a more benefits of PPCI, such as reduction of stroke and complex algorithm where the potential for reinfarction, are not lost at this time period. confusion, or even error, is greater. www.improvement.nhs.uk/heart
  • 7. A Guide to Implementing Primary Angioplasty 7 When setting up a service, it is important to normal day, and are then called back in for a note that 120 minutes is an aspirational time to single PPCI procedure, then the European treatment and is not a defined quality standard. Working Time Directive (EWTD) states that they Based on the largest body of evidence to date, should have 11 hours continuous rest within any PPCI may be the optimum strategy provided the 24 hour period. If the procedure ran from 4am call-to-balloon time does not exceed 150 until 5am, then the staff would not be expected minutes (i.e. the equivalent of a call-to-needle to work again until 4pm that day. time of 30 minutes plus the 114 minutes during The unpredictability of PPCI presentations, and which PPCI is superior to thrombolysis). the subsequent unpredictability of staff At a national consensus meeting (September availability the following day, is a problem for all 2008), chaired by Professor Roger Boyle, there 24/7 PPCI centres but may be easier to manage was clear national consensus that cardiac in a large centre with six catheter labs and a networks should take the lead on developing large staff pool than in a centre with a single their local 24/7 PPCI service (appendix 2). cardiac catheter lab. Some organisations (e.g. West Midlands) have mandated that PCI centres Does every PCI centre need to provide with a single catheter lab should not be set up 24/7 PPCI? as PPCI centres. There are 69 NHS PCI centres in England; less It is important that any centre starting a primary than one-third of these currently provide a 24/7 PCI programme understands that primary PCI is PPCI service (4). The remaining centres provide different from other forms of PCI. Patients are either no PPCI service or service during restricted sicker, complications are more frequent and hours only (usually Monday to Friday 9-5). there is greater requirement for intra-aortic Working on a rate of presentation of STEMI balloon pumping, mechanical variation etc. The patients of 600 per million of the population per BCIS national PCI audit shows that the mortality annum, and on the assumption that 22% of for primary PCI is around 4.6-4.8% (3). This is patients present between midnight and 8am (5), approximately six times the mortality for NSTEMI eighteen patients, on average, will present with PCI and more than twenty times the mortality STEMI each night (midnight to 8am) in England. risk for elective PCI. It therefore seems sensible To have all 69 cath labs in England staffed and that centres should only undertake primary PCI available to perform PPCI, but waiting for just if they have 24-hour consultant cardiology 18 patients, would be hugely wasteful. availability (i.e. a consultant cardiology rota) to Furthermore, PCI centres with a single cardiac manage patients following PPCI for STEMI. This catheter lab may find their daytime work may be an issue with some non 24/7 PCI schedule disrupted if they attempt to run a 24/7 centres. PPCI service. If cardiac catheter lab staff work a www.improvement.nhs.uk/heart
  • 8. 8 A Guide to Implementing Primary Angioplasty Local factors and local geography will influence Should a non 24/7 PCI centre how many PPCI centres are required. In most perform any PPCI? densely populated areas of England, particularly If we consider a cardiac network with one 24/7 if there are good transport links, one 24/7 PPCI PCI centre and three PCI centres where the centre should comfortably be able to serve a cardiac catheter labs are non 24/7, then there population of 1.5 - 2 million. are three possible treatment scenarios for STEMI patients: (appendix 3). Does the size of a PCI centre affect patient outcomes? 1.all STEMI patients are transferred directly to the 24/7 centre. This would include any STEMI This has been a contentious area for a number patients who present directly to hospitals of years. However, there is growing evidence operating a non 24/7 PCI service. that, in the setting of acute PCI for STEMI, 2.all STEMI patients are taken to the nearest patient outcomes are better in centres with a cardiac catheter lab. This means that a larger volume of cases. In Germany, an analysis proportion of patients would be taken for PPCI of almost 28,000 patients compared outcomes to the non 24/7 centres although the majority in larger with smaller centres. There were no (those presenting between 5pm and 8am mortality differences for patients without a Monday to Friday plus all weekend and Bank myocardial infarction. Among those patients Holiday presenters) would be taken to the with an acute myocardial infarction, there was a 24/7 centre. stepwise (and significant) reduction in mortality 3.all STEMI patients diagnosed by the when moving from low volume to high volume ambulance service are taken directly to the centres. Centres in the top quartile for volume 24/7 centre but the small number who self- (performing > 521 procedures per year) had a present at the non 24/7 PCI centre would have mortality of 2.78% compared with 3.97% for their procedure locally provided the cardiac centres performing 196-323 procedures per year catheter lab was available. and 4.41% for centres performing less than 166 procedures per year (6). All three options have their advantages and disadvantages. Analysis of the greater Paris PCI registry showed similar results. Death rates for planned Option 1 is the simplest from the organisational procedures were low and equivalent for small viewpoint; it provides a single route of referral (<400 cases per year) and larger (>400 cases per (and single phone call) regardless of the time of year) centres. For emergency procedures, day or day of the week. Furthermore, with the however, the mortality rate was significantly advent of designated centres for major trauma lower in the centres performing more than 400 and stroke disease, ambulance services are now cases per year (6.75% vs 8.54%, p<0.05)(7). increasingly familiar with the concept of bypassing a local hospital in order to deliver a www.improvement.nhs.uk/heart
  • 9. A Guide to Implementing Primary Angioplasty 9 the ambulance is essential to allow the catheter lab to prepare for the patient’s arrival. For out- of-hours referrals, the pre-alert allows the staff to travel to the hospital while the patient is being transported. Thus a travel time of 60-90 minutes may be perfectly reasonable if this is the time taken for all the catheter lab staff to travel to the PCI centre and prepare for the patient’s procedure. Provided the patient is taken directly to the cardiac catheter lab (and not to Accident patient to a specialist treatment centre. For this and Emergency or to Coronary Care), then it reason, this is the preferred option in many areas should still be possible to meet the 120 minute of the country (London, Newcastle, South Tees, call-to-balloon time. Door-to-balloon times may West Yorkshire, and Greater Manchester). be affected by the size of the centre. During normal working hours, door-to-balloon times Option 2 is organisationally more complex but may be shorter in a 24/7 centre with six cardiac provides shorter transport times for weekday catheter labs, four of which are engaged in PCI daytime presenters. Some ambulance services than in a non 24/7 centre with a single cardiac prefer this option because their vehicles are less catheter lab, particularly if the pre-alert time is likely to be ‘off site’ during the day. However, short. However, the balance between a shorter many ambulance service Medical Directors say transport time and a possibly longer door-to- the uncertainty about what to do with a patient balloon time will depend on local geography at 8.30 am or 4.45 pm makes this system and will need to be monitored closely, whatever unwieldy. If this option is considered further, the option is chosen. non 24/7 centre must make an absolute commitment to provide PPCI between the Regardless of where the PPCI procedures take agreed hours every normal working day place, consideration should be given to those regardless of other commitments. interventionists working at non 24/7 centres contributing to the regional out-of-hours on-call Option 3 is a variation of option 2; it has the rota. There are 547 trained interventional disadvantage that the 9-5 centre will see very cardiologists in the UK (3). If out-of-hours PPCI is few PPCI patients and will struggle to maintain provided by 20-25 centres in the UK, then the and develop skills. on-call frequency could be as low as one night When planning services, it is important to realise every three weeks. In practice, those at the non that the travel time (in the ambulance) is only 24/7 centres will have other on-call one component of the call-to-balloon time. The commitments and a full commitment to the rota door-to-balloon time within the hospital is also is often not practical. Nevertheless, any an important component. A ‘pre-alert’ call from contribution to the regional rota at the 24/7 www.improvement.nhs.uk/heart
  • 10. 10 A Guide to Implementing Primary Angioplasty centre is generally welcomed. An appropriate In West Yorkshire, PPCI commenced in programmed activity (PA) calculation for the Leeds in April 2005 and was later rolled average amount of work done during on-call out to the rest of the network. For each should be made and this reimbursed from the patient, Leeds PCT paid the acute PCI 24/7 to the non 24/7 trust. This system already tariff. However, it no longer paid the MI works well in some areas of the country and tariff and had to pay for a smaller number helps to maintain and develop the skills of those of subsequent angiography and PCI interventionists based at hospitals not providing procedures. This resulted in a saving to a PPCI service. Leeds PCT of £750,000 in the first year. For subsequent years, Leeds PCT reduced Commissioning a PPCI service the SLA with Leeds Teaching Hospitals NHS Trust for MI stays and subsequent In some ways, commissioning of a PPCI service angiograms and the ‘savings’ were differs from the commissioning of other new directed into other services (8). clinical services. The procedure (PCI) is already commissioned. Initial fears that commissioning a Indeed, the overall cost to commissioners of PPCI service might lead to a substantial growth treating STEMI may fall following the in total PCI numbers have been unfounded. In introduction of PPCI. West Yorkshire, the introduction and roll-out of PPCI to a population of around three million has Steps: led to no increase in absolute PCI numbers, even though PPCI now makes up 30% of the total 1. A network-wide discussion on the PCI procedures. The reason for this is clear: number and location of centres that will when thrombolysis was the standard treatment provide PPCI. This will be determined by for STEMI patients, around 60-70% of geography, access to the centres and the thrombolysed patients underwent angiography expected number of PPCI cases. These data and/or PCI within six months of their initial should be available from the MINAP report (4). presentation. Therefore, a policy of PPCI brings As noted earlier, this is unlikely to represent a forward the PCI procedure to the time when the significant increase in PCI activity unless the pre- patient has most to gain. existing level of intervention in the network was particularly low. The service may be provided by a mixture of 24/7 and non 24/7 PCI centres (see The NIAP recommendation was simply that: above). If a PCI service serves a population of “the procedures should be carried 500,000, and runs a 24/7 service, then it would expect to see around 300 PPCI patients per out in a centre with a sufficiently annum. If the service is 9-5, 365 days per year, high volume of cases to maintain then it would expect to treat around 58% of all and develop skills.” PPCI patients in the area. If the service runs 9-5, www.improvement.nhs.uk/heart
  • 11. A Guide to Implementing Primary Angioplasty 11 Monday to Friday, and is closed on Bank 2. Equality Impact Assessment. Local data Holidays, then it would expect to perform PPCI and community intelligence will be required to on approximately 40% of all STEMI patients assess the needs of the population and to from its catchment area (i.e. 2-2.5 procedures provide equitable access for patients in rural per week on average). areas will require longer ambulance journey times. In areas with very long travel times to the There is a risk of very patchy and fragmented PPCI centre it may be appropriate to continue services being developed. Smaller PCI centres with a pre hospital thrombolysis service with the (e.g. with two or three PCI operators) may feel patients then transferring to a PCI centre for threatened by the loss of some PCI activity to angiography/PCI within a 24-hour timeframe (9). their local 24/7 PCI centre and may feel obliged to develop a 9-5 Monday to Friday PPCI service. 3. Setting up a 24/7 service. The 24/7 PCI It is clearly important that the best interests of centre is likely to require additional non-medical the patients are the primary concern. As noted staff (nursing staff, cardiac physiologists and earlier, the mortality risk for STEMI patients radiographers) to cope with the increased undergoing PCI is approximately six times the frequency of out-of-hours and weekend mortality for non-STEMI PCI. These patients, working. With a high expectation of night therefore, require access to a highly trained team working, there may be a knock-on effect to in the catheter laboratory and in the coronary daytime staffing which needs to be considered. care unit. If the procedure has been complicated, If the European Working Time Directive is patients will require further specialist cardiology observed, then staff who work after midnight input at any time of the day or night. For this will normally be allowed 11 hours’ rest prior to reason, setting up a 9-5 PPCI service in a hospital returning to work. This will require a larger without a consultant cardiology rota is not workforce and flexibility in the workforce. Under recommended. When considering 9-5 centres, Payment by Results (PBR), there is no additional the network, the commissioners and the funding for a PPCI procedure carried out at 3am ambulance trust(s) need to balance carefully the compared to one at 3pm. As mentioned earlier, benefits of shorter transfer times for a minority the increase in total PCI numbers may be very of the patients presenting for PPCI against the modest. The PPCI centre, therefore, will incur published data (outlined above) relating larger additional staffing costs which will not procedural volumes to better patient outcomes. necessarily be balanced by extra income under At present, there is no national recommendation PBR. Furthermore, some staff members may on the minimum number of PPCI procedures have chosen cardiac catheter laboratory work that should be performed by any centre. specifically because the daytime hours of However, one advisory group has recommended working, with a low frequency of night-time that only PCI centres performing more than 400 working, suited their domestic circumstances. PCI procedures per annum should be commissioned as primary PCI centres. www.improvement.nhs.uk/heart
  • 12. 12 A Guide to Implementing Primary Angioplasty The shift towards more frequent out-of-hours working will require careful planning. If additional staff are not employed, the delivery of daytime cardiac catheter lab work (elective PCI, angiography, pacing, EP etc) is likely to be compromised. 4. Return to local hospital. One of the advantages of a PPCI policy is that it shortens hospital stay when compared to thrombolysis, most patients being discharged on day three. Depending on local arrangements, the patient straightforward when there is a specific tariff for may remain in the PCI centre and then be rehabilitation which will usually be paid to the discharged directly home; in other centres, local hospital. patients are transferred back to the local hospital a few hours after the PPCI procedure. This is 6. Commissioning of the ambulance service. sometimes referred to as ‘repatriation’ although The ambulance service is the cornerstone to the patient may well have been admitted directly providing timely PPCI. As with stroke and serious to the PCI centre via the ambulance service and trauma, PPCI represents a major change in the may never have been in the local hospital. function of ambulance personnel who now play 5. Impact of PPCI on the DGH. A policy of a key role in diagnosis and in determining where PPCI will have a major effect on the function of the patient will be best treated. Setting up the the district general hospital (DGH) coronary care service, therefore, requires careful modelling of unit (CCU). The emphasis on the DGH CCU will exactly what is required. In general, the change from treating thrombolysed STEMI ambulance service is not required to make patients to treating post-PPCI patients and additional emergency journeys with STEMI NSTEACS patients. PPCI will also have an impact patients although the journeys will be longer if on DGH income. In some centres, because of the patient bypasses the local hospital. Return of the overall savings, PCTs have agreed to pay a the patient to the local hospital after PPCI may PCI tariff to the PCI centre and an additional be a new service; in many instances, however, ‘short stay tariff’ to the DGH which takes the patients received thrombolysis at their local patient soon after the PPCI procedure. In other hospital and were then transferred, by centres, a ‘tariff split’ arrangement has been ambulance, to a PCI centre. In each network, discussed with, for example, 80% of the PCI the amount of additional ambulance activity tariff going to the PCI centre and 20% to the required will depend on the model of PPCI hospital which takes the patient within 24 hours delivery chosen and on the pre-existing of the procedure. This may become more arrangements for inter-hospital transfer of MI www.improvement.nhs.uk/heart
  • 13. A Guide to Implementing Primary Angioplasty 13 patients and their families developing misconceptions about heart attack as an acute self limiting event rather than a marker of a long term condition (10). They believe the problem has been ‘fixed’. If the long term nature of the condition is not appreciated by the patient and their family, then the impact of advice about behaviour modification such as smoking cessation, weight loss, and regular exercise may be reduced. The provision of patients. Isochrone mapping of journey times information about prescribed medications, may be a useful tool when calculating journey dietary recommendations and levels of physical times to PPCI centres. exercise are important for patients and their families. Additional support may be required for 7. Rehabilitation and longer term elderly patients, those managing multiple co management. Patients treated with primary morbidities or those who have experienced angioplasty have a shorter hospital stay complications (eg cardiac arrest). Patients and characterised by transfers across clinical settings. families are not always certain of where hospital An unintended consequence of this is the care ‘finishes’ and community care ‘begins’ so reduction in time available for health information about who they may contact if they professionals to provide the patient and family experience difficulties during early recovery is with health education and psychological valuable. support. To ensure that patients do not ‘fall through gaps’ clear communication is required between acute services and the primary care trust. The involvement of cardiac rehabilitation teams during the early planning phase of services is recommended. Cardiac rehabilitation services may require additional resources with emphasis upon service delivery in a primary care rather than acute care setting. Effective discharge planning and timely referral for cardiac rehabilitation supports early recovery and secondary prevention. 8. Impact of families and carers. Another unintended consequence of PPCI is that the short hospital stay may contribute towards www.improvement.nhs.uk/heart
  • 14. 14 A Guide to Implementing Primary Angioplasty Help with implementation Summary NHS Improvement - Heart Improvement The implementation of PPCI as the default Programme is providing support for the treatment nationally for patients with STEMI cuts implementation of PPCI as stated in ‘Treatment across many boundaries. Those cardiac networks of Heart Attack National Guidance’. This support who have not yet implemented PPCI can learn a is in the form of a series of themed national great deal from the areas of the country where meetings and bespoke support for cardiac the service is already up and running. The networks and SHAs from the national clinical experience of the North East of England, one of lead and national improvement lead for the NIAP pilot sites, summarises the major reperfusion. Up to date information, resources issues. They concluded that the implementation and case studies are available on a dedicated of PPCI across the region revolved around web page on the NHS Improvement website. finding acceptable answers to five key questions: Further information and contact details 1. What are the patient pathways associated can be found on the website at: with the implementation of PPCI? www.improvement.nhs.uk/heart/reperfusion 2. What is the appropriate Payment by Results structure for funding these pathways? 3. What are the additional ambulance services required to support these pathways? 4. What is the knock-on impact to non-PPCI units of moving to PPCI? 5. What are the commissioning impacts for all PCTs and acute trusts in the region, including the one-off consequences of commissioning change and the sustained revenue consequences and impact on system-wide viability? www.improvement.nhs.uk/heart
  • 15. A Guide to Implementing Primary Angioplasty 15 Appendix 1: Key Studies in Primary PCI 1. Primary PCI versus intravenous additional ambulance journey and a delay in thrombolytic therapy for acute myocardial starting the reperfusion treatment. The median infarction: a quantitative review of 23 time interval from randomization to the start of randomised trials. treatment was 20 minutes (range 15-30 The Lancet 2003;361:13-20 minutes) for those patients in community Keeley E, Boura J, Grines C. hospitals treated with thrombolysis and 90 minutes (range 74-108 minutes) for those In this metanalysis of 23 randomised trials, patients transported to a PPCI centre. involving 7,739 patients, primary PCI was associated with significant reduction in death 3. Hospital Delays in Reperfusion for ST- (7% vs 9%), non-fatal re-infarction (3% vs 7%) Elevation Myocardial Infarction: Implications and stroke (1% vs 2%). However, the studies When Selecting a Reperfusion Strategy. included in this metanalysis relate to patients Pinto DS, Kirtane AJ, Brahmajee K, et al. presenting to PCI centres. In the UK, many Circulation 2006;114:2019-2025. patients present acutely to non-PCI hospitals. In this observational study, the inherent delay in 2. A comparison of coronary angioplasty PPCI was calculated by subtracting door-to- with fibrinolytic therapy in acute needle times from door-to-balloon times in a myocardial infarction. very large registry of 192,000 MI patients. After Anderson HR, Nielsen TT, Rasmussen K, et al correction for patient and hospital-based factors, N Engl J Med 2003;349:733-742 the timepoint at which the odds of death with PCI were equal to those for thrombolysis In the studies included in the metanalysis occurred when the PCI delay (i.e. the difference described above (Keeley et al), patients between door-to-needle and door-to-balloon presenting to a PCI-capable hospital were times) was 114 minutes. randomised to either PPCI or thrombolysis. In this study (DANAMI-2), 1129 patients presenting to non-PCI centres were randomised to either immediate thrombolysis (at the community hospital) or to transportation by ambulance to a PCI centre for primary PCI. The primary end- point (death, re-infarction or disabling stroke) was significantly lower in the PPCI group than in the thrombolysis group (8.5% vs 14.2%, p<0.002) even though the PPCI group had an www.improvement.nhs.uk/heart
  • 16. 16 A Guide to Implementing Primary Angioplasty Appendix 2: National PCI Consensus Meeting A national PCI consensus meeting was held by 2. Workforce NHS Improvement on 24th September 2008. Workforce issues for all catheter lab staff were Invited to the meeting were cardiac network discussed. Centres should observe the European representatives and interventional cardiologists Working Time Directive with regard to rest for from large (surgical) centres, from PCI centres on-call staff who have been working during the without on-site surgical cover and from DGHs night. For consultant staff, this means altering planning to set up PCI services. Speakers job plans so that the consultant has no fixed included Dr Roger Boyle (National Director for commitments after a night on-call. It was Heart and Stroke), Dr Huon Gray (Author of the acknowledged that this may have adverse NIAP report) and Dr Mark de Belder (President of effects on catheter lab scheduling and the British Cardiovascular Intervention Society). productivity. The discussion centred on the current status of Possible destabilisation and recruitment issues PCI delivery in the UK, requirements for new were discussed. This could be destabilisation of centres to deliver more PCI, the role of cardiac the DGH with deskilling of CCU staff if the care networks and issues around measuring and of STEMI patients transfers from a DGH to a reporting quality. 24/7 PCI centre. On the other hand, 24/7 The main areas of agreement working may cause some staff to move away consensus were: from the 24/7 PCI centre to a non-24/7 PCI centre. 1. Networks Agreement was reached that networks are the 3. British Cardiovascular Intervention correct building blocks for planning PCI services. Society (BCIS) Cardiac networks are patient focused and The majority agreed that the BCIS peer review provide a forum to arrive at a clinical consensus scheme was still required and BCIS had a role in on patient care. They are able to discuss the the accreditation of new centres and in setting, whole patient pathway across boundaries able and publishing, agreed standards. to take a strategic view and influence trusts. 4. Measuring and reporting quality There was also agreement that cross boundary There was general agreement that quality in PCI working is required to deliver equitable services is difficult to measure and that more robust for patients. Cross boundary working was outcome data are required including evidence especially pertinent for working with ambulance relating volume of activity to outcomes. services. www.improvement.nhs.uk/heart
  • 17. A Guide to Implementing Primary Angioplasty 17 Appendix 3: Treatment Options for STEMI Option 1 Patient with STEMI Call 999 GP Self presents in A&E 24/7 heart attack centre Option 2 Patient with STEMI Call 999 GP Self presents in A&E Local hospital Local hospital Out of hours 24/7 heart Out of hours Weekends attack centre Weekends Bank holidays Bank holidays Option 3 Patient with STEMI Call 999 GP Self presents in A&E 24/7 heart When catheter labs are unavailable attack centre Local hospital www.improvement.nhs.uk/heart
  • 18. 18 A Guide to Implementing Primary Angioplasty References 1. Department of Health (2008) Treatment of Heart Attack National Guidance – Final Report of the National Angioplasty Project (NIAP) 2. Darzi A (2008) High Quality Care for All 3. British Cardiovascular Intervention Society (2007) Audit report www.bcis.org.uk/resources/audit 4. Royal College of Physicians (2008) Myocardial Ischaemia National Audit Report (MINAP) How the NHS manages heart attacks 5. Primary percutaneous coronary intervention for acute ST segment elevation myocardial infarction - first year’s experience of a tertiary referral centre in the UK. Dorsch MF, Blackman DJ, Greenwood J, et al Clinical Medicine 2008;8:259-263. 6. Volume-outcome relation for contemporary percutaneous coronary interventions (PCI) in daily clinical practice: is it limited to high-risk patients? Results from the Registry of Percutaneous Coronary Interventions of the Arbeitsgemeinschaft Leitende Kardiologische Krankenhausarzte (ALKK). Zahn R, Gottwik M, Hochadel M, et al. Heart 2008;94:329-335 7. Is the volume-outcome relation still an issue in the era of PCI with systematic stenting? Results of the greater Paris area PCI registry. Spaulding C, Morice MC, Lancelin B, et al. European Heart Journal 2006;27:1054-1060 8. West Yorkshire Cardiovascular Network (2008) – personal communication 9. ‘Management of acute myocardial infarction in patients presenting with persistent ST elevation’ European Society of Cardiology Guidelines Van de Werf F, Bax J, Betriu, et al. European Heart Journal (2008) 29,2909-2945 10.Primary angioplasty for heart attack: mismatch between expectation and reality. Astin F, Closs SJ, McLenachan JM, et al Journal of Advanced Nursing 2008;65:72-83 Authors Dr J M McLenachan, National Clinical Lead, Reperfusion, NHS Improvement, Consultant Cardiologist, Leeds General Infirmary Carol Marley, National Improvement Lead, Reperfusion, NHS Improvement Sheelagh Machin, Director, Heart, NHS Improvement April 2009 www.improvement.nhs.uk/heart
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  • 20. NHS NHS Improvement CANCER DIAGNOSTICS HEART STROKE NHS Improvement With nearly ten years practical service improvement experience in cancer, diagnostics and heart, NHS Improvement aims to achieve sustainable effective pathways and systems, share improvement resources and learning, increase impact and ensure value for money to improve the efficiency and quality of NHS services. Working with clinical networks and NHS organisations across England, NHS Improvement helps to transform, deliver and build sustainable improvements across the entire pathway of care in cancer, diagnostics, heart and stroke services. NHS Improvement 3rd Floor | St John’s House | East Street | Leicester | LE1 6NB Telephone: 0116 222 5184 | Fax: 0116 222 5101 www.improvement.nhs.uk Delivering tomorrow’s improvement agenda for the NHS ©NHS Improvement 2009 | All Rights Reserved Publication Ref: IMP/heart0014